National disclosure audio conference Analysis of the revised

National disclosure audio conference: Analysis of the revised Physician Payments Sunshine Act and state drug marketing laws February 10, 2009 “Where we are today on state and federal disclosure, transparency and aggregate spend? ” Presented by Jennifer Colapietro Pw. C

Current state of disclosure Consistent with theme of transparency embraced by the new Obama administration, there is a push for stricter and tougher requirements on the industry to openly share with the public the financial investments they are making in Healthcare Professionals (HCPs). • • • California District of Columbia Maine Minnesota Nevada Vermont National disclosure audit conference: Analysis of the revised physician payments sunshine act and state drug marketing laws Pricewaterhouse. Coopers • West Virginia • Newly passed—Massachusetts (first disclosure report is due 7/1/2010 for time period 7/1/09– 12/31/09) • Pending—Physician Payments Sunshine Act 1

Where are manufacturers today? A majority of manufacturers have already taken steps to address the physician reporting requirements enacted in the various states. • Incorporated state disclosure requirements and thresholds within existing policies and procedures • Interpreted state requirements to understand data attributes necessary to report and mapped to source systems for data retrieval • Formalized processes and responsibilities for data collection, consolidation, validation, and reporting • Developed short-term, semi-automated solutions Primarily still a manually-intensive, cumbersome process to gather, consolidate, validate and report total physician spend National disclosure audit conference: Analysis of the revised physician payments sunshine act and state drug marketing laws Pricewaterhouse. Coopers 2

Data is captured in disparate systems The majority of the data that is required to be reported is either manually captured, is duplicated in multiple systems and needs to be reconciled, and/or is resident in siloed applications or data repositories across the organization. Payment types: • • Gifts (including text books and models) Meals Entertainment Honoraria and expenses associated with: - • • Speaker programs Advisory Boards Consulting agreements CME Grants Bona fide clinical trial expenses Advertising spend in state Aggregate employee/contractors costs associated with advertising/ promo activities National disclosure audit conference: Analysis of the revised physician payments sunshine act and state drug marketing laws Pricewaterhouse. Coopers Required data attributes reside in separate systems and contracts within: • • Sales Marketing Medical affairs Finance (including expense systems) Legal HR Research and Development Third-Party Vendors 3

Unique customer identification is necessary for aggregate reporting The effort to gather and align the data to individual health care professionals becomes even more difficult as each department/business unit often has a separate profile established to identify the physician. • Most companies have established a Sales and Marketing Customer Master for matching/ merging, unique identification, and profiling • But few companies have achieved the ideal state of an enterprise-wide Customer Master to match all profiles and establish a unique HCP ID across Sales, Marketing, Medical Affairs, R&D, and Finance • More stringent reporting requirements require an understanding of organizational hierarchy and affiliations National disclosure audit conference: Analysis of the revised physician payments sunshine act and state drug marketing laws Pricewaterhouse. Coopers 4

Current Infrastructure is not sustainable if Federal Physician Payments Sunshine Act is passed There are certain "must-dos" for companies to prepare for and comply with respect to the new Federal Physician Payments Sunshine regulations. Highlights of pending federal legislation: • Applicable to all manufacturers of a covered drug, device, biologics or medical supply, including GPO ownership disclosure • Report payments to all physicians, physician medical practice, and physician group practice in US • Additional payment disclosures • New payment exceptions • Additional reporting attributes required • Stronger penalties • Public availability National disclosure audit conference: Analysis of the revised physician payments sunshine act and state drug marketing laws Pricewaterhouse. Coopers Current state assessment: • Assess the impact to current interpretation, processes, organizational impact, data integration, supporting applications, reporting, communication and training Data access, integration and reporting: • Define the best strategy for extracting and aligning the new data to report total aggregate health care provider spend Customer master enhancements: • Determine a future strategy to establish a single consistent view of the customer across the company 5

Physician Payments Sunshine Act presents a new opportunity • Physician payment reporting is generally reactive and typically viewed by the industry as an administrative burden required to meet regulations • Manufacturers have a unique opportunity to do more than just put in the basic systems, processes and controls to ensure compliance. They have an opportunity to: - Raise the bar for corporate compliance efforts - Improve industry perception and relationships with its consumers, the regulators and other key stakeholders - Better link compliance and business operations and drive additional value to the business beyond just compliance National disclosure audit conference: Analysis of the revised physician payments sunshine act and state drug marketing laws Pricewaterhouse. Coopers 6

Compliance as a competitive advantage If companies truly want to drive value to the business with this investment, they should strongly consider using this as an opportunity to establish an integrated, transparent system and obtain the associated benefits: • • Risk mitigation Cost reduction Efficiency Effectiveness Corporate integrity Positive public perception Actionable insight for better business decision making, resource allocation, and avoidance of conflict of interests National disclosure audit conference: Analysis of the revised physician payments sunshine act and state drug marketing laws Pricewaterhouse. Coopers 7

What you should do now? To accomplish this improved state of transparency, companies should consider establishing the following: • Corporate vision for transparency—Establish a global strategy and vision for what transparency can mean to your organization and how it can provide a competitive advantage both from an internal and external stakeholder perspective • Streamline and standardize—Consider aggregate spend in light of your other performance improvement initiatives focused on finance effectiveness, healthcare compliance, FCPA, Sales and Marketing cost reduction, R&D efficiency, corporate reporting and analytics, or IT/data management initiatives • Proactive monitoring and actionable analytics—Establish and operationalize an enterprise wide framework for transparent monitoring, reporting, and analysis with Key Performance Indicators (“KPIs”) and dashboards used to detect and prevent issues National disclosure audit conference: Analysis of the revised physician payments sunshine act and state drug marketing laws Pricewaterhouse. Coopers 8

Thank you! For questions please contact: Jennifer Colapietro Director, Global Pharmaceutical and Life Sciences Group Pricewaterhouse. Coopers jennifer. a. colapietro@us. pwc. com 973. 236. 4124 National disclosure audit conference: Analysis of the revised physician payments sunshine act and state drug marketing laws Pricewaterhouse. Coopers 9

www. pwc. com © 2009 Pricewaterhouse. Coopers LLP. All rights reserved. "Pricewaterhouse. Coopers" refers to Pricewaterhouse. Coopers LLP (a Delaware limited liability partnership) or, as the context requires, other member firms of Pricewaterhouse. Coopers International Ltd. , each of which is a separate and independent legal entity. *connectedthinking is a trademark of Pricewaterhouse. Coopers LLP. Pw. C